Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT05742035
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2023-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.
Sponsor:
Interregionale Blutspende SRK
Organization:
Study Overview
Official Title:
Quality and Biologic Characteristics of Red Blood Concentrates Obtained From Individuals With Elevated Ferritin.
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Iron overload in hereditary hemochromatosis (HH) is treated by phlebotomy. It is unclear, if individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes are suitable as blood donors. The study investigates hemolysis and several other quality parameters of red blood cell concentrates (RBC) obtained from 80 individual with ferritin \>500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control.
Detailed Description:
Iron overload in hereditary hemochromatosis is treated by phlebotomy. In Switzerland and in many other coutries, these individuals are not accepted for blood donation until ferritin values and phlebotomy intervals are in the normal range.
Individual with secondary hyperferritinemia, e. g. related to metabolic syndrome, are accepted as blood donors according to their clinical situation.
It is unclear if the quality of blood products issued from individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes is comparable with the quality of those issued from healthy blood donors, and if their characteristics comply with the international standards.
The study investigates the hemolysis rate and several other quality parameters in RBC obtained from 80 individual with ferritin \>500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control. For this purpose, whole blood donations are manufactured according to the standard processes applied in the blood bank. Several standard quality parameters as well as biologic, rheologic, and oxydative stress-related variables are measured and compared, both with the current regulations and with those of the control group.
Individual with secondary hyperferritinemia, e. g. related to metabolic syndrome, are accepted as blood donors according to their clinical situation.
It is unclear if the quality of blood products issued from individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes is comparable with the quality of those issued from healthy blood donors, and if their characteristics comply with the international standards.
The study investigates the hemolysis rate and several other quality parameters in RBC obtained from 80 individual with ferritin \>500 ng/mL - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control. For this purpose, whole blood donations are manufactured according to the standard processes applied in the blood bank. Several standard quality parameters as well as biologic, rheologic, and oxydative stress-related variables are measured and compared, both with the current regulations and with those of the control group.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: